VestibulodyniaPhase 3VESTIBULENCT02858219
A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia
A Phase 3 study testing Botulinum Toxin Type A, Saline solution and Indexes in people with Vestibulodynia, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
Trial summary
The main objective of this study is to compare the efficacy of botulinum toxin injections on vestibulodynia pain compared to a group treated with a placebo. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Vestibulodynia
- What is being tested?
- Botulinum Toxin Type A, Saline solution and Indexes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 4 May 2010to 11 Feb 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subject refractory to conventional treatments (tricyclic antidepressants and benzodiazepines at analgesic doses, biofeedback physical therapy)
- Negative screening test results
- Notified associated factors
- Menopause, surgically sterilized women or women using effective contraceptive method
- Good understanding and predictable adherence to the protocol
- beneficiary/affiliated to French social security/social healthcare
- signed Informed Consent Form
Who cannot join
- Predictable poor adherence
- Pregnant or breastfeeding women
- Myasthenia
- Treatment with aminoglycosides
- Major mental disorders
- Underlying etiology
Show all 9Show fewer
- Vulnerable subjects (particularly adults under guardianship)
- Any reason deemed relevant by the investigator
- Current or former (in the last 3 months) participation to another clinical trial
Trial locations and contacts
2 sites in 1 country.
About this study
The main objective of this study is to compare the efficacy of botulinum toxin injections on vestibulodynia pain compared to a group treated with a placebo.
- Conditions
- Vestibulodynia
- Being tested
- Botulinum Toxin Type A, Saline solution, Indexes
- Keywords
- Botulinum toxin, Pain improvement
- Medical subject headings
- Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline solutionOther
IndexesOther
Visual Analogic Scale (VAS), Female Sexual Function Index (FSFI), Dermatology Life Quality Index (DLQI)
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin | Experimental | Injection of 50 units (50U) botulinum toxin type A (powder), reconstituted in 1 mL physiologic saline solution in each perineal muscle (100 units in total).
First injection at day 1 and. A second injection is scheduled at 3 months, only if there is a 50% or more pain improvement compared to baseline (pain measured with Visual Analogic Scale). Receives: Drug: Botulinum Toxin Type A; Other: Indexes |
| Saline solution | Placebo comparator | Injection of 1 mL physiologic saline solution in each perineal muscle. A second injection is scheduled at 3 months, only if there is a 50% or more pain improvement compared to baseline (pain measured with Visual Analogic Scale). Receives: Other: Saline solution; Other: Indexes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain improvement
Significant improvement of pain on contact in the treated group, compared to placebo group, measured with Visual Analogic Scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study start4 May 2010
- Primary completion11 Feb 2019
- Study completion11 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VestibulodyniaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabien Pelletier, MD, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858219
- Sponsor's protocol ID
- API/2011/20
- Acronym
- VESTIBULE
- Status last verified
- Nov 2022
- First submitted
- 1 Aug 2016
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia
- ClinicalTrials.gov ID
- NCT02858219
- Acronym / sponsor ID
- VESTIBULE / API/2011/20
- Conditions
- Vestibulodynia
- Keywords
- Botulinum toxin, Pain improvement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 4 May 2010 (actual)
- Primary completion
- 11 Feb 2019 (actual)
- Study completion
- 11 Feb 2019 (actual)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to compare the efficacy of botulinum toxin injections on vestibulodynia pain compared to a group treated with a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin | Experimental | Drug: Botulinum Toxin Type A, Other: IndexesInjection of 50 units (50U) botulinum toxin type A (powder), reconstituted in 1 mL physiologic saline solution in each perineal muscle (100 units in total). First injection at day 1 and. A second injection is scheduled at 3 months, only if there is a 50% or more pain improvement compared to baseline (pain measured with Visual Analogic Scale). |
| Saline solution | Placebo comparator | Other: Saline solution, Other: IndexesInjection of 1 mL physiologic saline solution in each perineal muscle. A second injection is scheduled at 3 months, only if there is a 50% or more pain improvement compared to baseline (pain measured with Visual Analogic Scale). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject refractory to conventional treatments (tricyclic antidepressants and benzodiazepines at analgesic doses, biofeedback physical therapy)
- Negative screening test results
- Notified associated factors
- Menopause, surgically sterilized women or women using effective contraceptive method
- Good understanding and predictable adherence to the protocol
Key exclusion criteria (9 listed)
- Predictable poor adherence
- Pregnant or breastfeeding women
- Myasthenia
- Treatment with aminoglycosides
- Major mental disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type A | Drug | Botulinum toxin |
| Saline solution | Other | Saline solution |
| IndexesVisual Analogic Scale (VAS), Female Sexual Function Index (FSFI), Dermatology Life Quality Index (DLQI) | Other | Botulinum toxin, Saline solution |
Primary outcome
Pain improvement
Time frame: 3 months
Significant improvement of pain on contact in the treated group, compared to placebo group, measured with Visual Analogic Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Vestibulodynia
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A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
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Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
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Efficacy of Dry Needling in Reducing Pain During Sexual Intercourse
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Biomodulation and Rehabilitation Interventions to tarGet Pelvic Health
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabien Pelletier, MD principal investigator
Centre Hospitalier Universitaire de Besancon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum Toxin Type A, Saline solution and Indexes in people with Vestibulodynia, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain improvement (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.